a study of gnc-077 in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors

Conditions: Gastrointestinal Tumors; Solid Tumor

Summary: this study is an open-label, multicenter, dose-escalation and cohort expansion phase i clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.


Eligibility criteria:
inclusion criteria: 1. able to understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. gender is not limited; 3. age: ≥18 years old and ≤75 years old (phase ia); ≥18 years old (phase ib); 4. patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors confirmed by histopathology and/or cytology who failed standard treatment; 5. must have at least one measurable lesion that meets the recist v1.1 definition; 6. have archived primary or recurrent tumor tissue specimens that can be submitted for central review; 7. ecog ≤1; 8. the expected survival time as judged by the investigators was ≥3 months; 9. bone marrow function, renal function and liver function need to meet the requirements; 10. coagulation function: fibrinogen ≥1.5 g/l; activated partial thromboplastin time (aptt) ≤1.5×uln; prothrombin time (pt) ≤1.5×uln; 11. fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose; 12. subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. exclusion criteria: 1. chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas were administered within 6 weeks before the first dose; oral drugs such as fluorouracil; 2. patients with active infection requiring intravenous antibiotics that had not been completed more than 1 week before enrollment, with the exception of prophylactic antibiotics for puncture or biopsy; 3. positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis b virus infection or hepatitis c virus infection; 4. toxicity from prior antineoplastic therapy is not reduced to grade i as defined in ctcae, version 5.0; 5. patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement; 6. pulmonary disease defined as ≥ grade 3 according to nci-ctcae v5.0; a history of ild requiring steroid therapy, or current ild or grade ≥2 radiation pneumonitis; 7. patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation; 8. had a history of severe cardiovascular and cerebrovascular diseases; 9. patients with or with unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening; 10. brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases; 11. patients with massive or symptomatic effusions or poorly controlled effusions; 12. imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries; 13. subjects with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened; 14. complicated with other malignant tumors within 3 years before the first administration; 15. poorly controlled hypertension (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 16. diabetic patients with poor glycemic control; 17. patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of gnc-077; 18. who had participated in a clinical trial of an unmarketed drug within 4 weeks before the trial dose; 19. had received a live vaccine within 4 weeks before the trial dose; 20. other circumstances that the investigator deemed inappropriate for participation in the trial.